TILAVIST 2% EYE DROPS

PDF Transcript

PATIENT INFORMATION LEAFLET

1316
30.06.15[7]

Rapitil™ 2% Eye Drops
Tilavist® 2% Eye Drops
Nedocromil Sodium 2% Eye Drops
(nedocromil sodium)
Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist. See
section 4.
Your medicine is available using any of the above names but will be
referred to as Rapitil Eye Drops throughout the following leaflet.
In this leaflet:
1. What Rapitil Eye Drops are and what they are used for
2. Before you use Rapitil Eye Drops
3. How to use Rapitil Eye Drops
4. Possible side effects
5. How to store Rapitil Eye Drops
6. Further information
1. What Rapitil Eye Drops are and what they are used for
What Rapitil Eye Drops are
Rapitil Eye Drops contain a medicine called nedocromil sodium. This
belongs to a group of medicines called anti-allergics.
How Rapitil Eye Drops work
It works by stopping the release of the natural substances in your eyes
that can lead to an allergic reaction.
What Rapitil Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic conjunctivitis’
(inflammation of parts of the eye). Rapitil Eye Drops can be used for three
types of allergic conjunctivitis:
 ‘Perennial allergic conjunctivitis’ in adults only: This type of allergy
can happen at any time of the year and is often caused by animal fur or
house dust mites. Signs include itchy, watery, red or inflamed eyes and
puffy eyelids.
 ‘Seasonal allergic conjunctivitis’ in adults and children: This type
of allergy, such as hay fever, can be caused by different pollens in
different seasons of the year. Signs include itchy, watery, red or
inflamed eyes and puffy eyelids.
 ‘Vernal kerato conjunctivitis’ in adults and children: This is a more
severe type of allergy. Signs include bumps inside the upper eyelid,
sensitivity to light and severe itching

2. Before you use Rapitil Eye Drops
Do not use this medicine and tell your doctor or pharmacist if:
 You are allergic (hypersensitive) to nedocromil sodium, or any of the
other ingredients of Rapitil Eye Drops (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue or around the
eyes
Do not use this medicine if the above applies to you. If you are not sure,
talk to your doctor or pharmacist before using Rapitil Eye Drops.

How much to use
Adults, Elderly and Children aged 6 years and over
Seasonal allergic conjunctivitis:
 One drop into each eye twice each day
 This can be increased to four times each day if needed
 Do not use for more than 12 weeks
Vernal kerato-conjunctivitis
 One drop into each eye four times each day

Take special care with Rapitil Eye Drops if:
 You wear soft contact lenses. You should not wear soft contact lenses
while using these drops
If you are not sure if this applies to you, talk to your doctor or pharmacist
before using Rapitil Eye Drops.

Adults and the Elderly only
Perennial allergic conjunctivitis:
 One drop into each eye twice each day
 This can be increased to four times each day if needed
 Use the drops regularly
Children under 6 years
This medicine is not recommended for children aged less than 6 years.

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant, might
become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your doctor or
pharmacist before taking or using any medicine.
Driving and using machines
Your eyesight may be affected after using this medicine. If this happens,
do not drive or use any tools or machines until you can see clearly.
Important information about some of the ingredients of Rapitil Eye
Drops
Rapitil Eye Drops contain benzalkonium chloride. This may cause your
eyes to become irritated. It may also change the colour of your contact
lenses.
3. How to use Rapitil Eye Drops
Always use Rapitil Eye Drops exactly as your doctor or pharmacist has
told you. You should check with your doctor or pharmacist if you are not
sure.
Using this medicine
 If you wear hard or gas-permeable contact lenses, you should take
them out while you use the eye drops. You should wait 15 minutes
before you put the contact lenses back in
 If you need to use more than one type of eye medicine, the medicines
must be used at least 5 minutes apart. Eye ointments should be used
last.
 If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor or pharmacist
How to use this medicine
 Wash your hands
 Remove the cap from the bottle
 Tilt your head back
 Squeeze one or two drops inside the
lower lid without touching your eye
 Close your eye
 Wipe away any excess liquid from the
eyes with a clean tissue
 Always put the cap back on the bottle as soon as you have used it
 Repeat in the other eye as needed

If you take more Rapitil Eye Drops than you should
If you use more Rapitil than you should, talk to your doctor or go to a
hospital straight away. Remember to take any medicine that is left with
you so the doctor knows what you have taken.
If you forget to use Rapitil Eye Drops
If you forget a dose, use your drops as soon as you remember. However,
if it is nearly time for your next dose, skip the missed dose. Do not use a
double dose to make up for a forgotten dose.
If you stop using Rapitil Eye Drops
Keep using the eye drops for as long as your doctor or pharmacist
advises you. If you stop using Rapitil Eye drops too early, your allergy
symptoms may come back.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Rapitil Eye Drops can cause side effects, although not
everybody gets them.
Stop using Rapitil Eye Drops and see a doctor as soon as possible
if:
 The itching, redness or swelling gets worse. You may be allergic to
these drops
Talk to your doctor or pharmacist if any of the side effects gets
serious or lasts longer than a few days, or if you notice any side
effects not listed in this leaflet:
Common (affects 1 to 10 people in a 100)
 Stinging or burning in your eyes or blurring of eyesight. This should only
last for a short time and occurs immediately after using the eye drops
 Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)
 Mild eye irritation

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Rapitil Eye Drops
Your eye drops should be kept in the original carton and do not store
above 25 ºC. Protect from direct sunlight.
Remember to keep all medicines out of the sight and reach of children.
You must not use the eye drops after the expiry date. This is given in two
places:
 on the end flap of the carton
 on the bottle label
In both places it is given as ‘EXP’ followed by the month and year. The
eye drops should not be used after the end of this month. If you are not
sure when this is, check with your doctor or pharmacist.
Discard the eye drops four weeks after opening for the first time.
Avoid contamination of the contents by replacing the cap securely after
use.
6. Further information
What Rapitil Eye Drops contain
The active ingredient is nedocromil sodium. Your eye drops contain 20mg
of nedocromil sodium per 1ml of solution. The solution also contains
benzalkonium chloride, sodium chloride, disodium edetate and purified
water.
What Rapitil Eye Drops look like and contents of the pack
Rapitil is available as yellow clear liquid in a plastic dropper bottle of 5ml.
Manufacturer and Product Licence Holder
Rapitil is manufactured by Sanofi Winthrop Industrie, Le Trait, France
and is procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1
1XD. Repackaged by Servipharm Ltd.
POM

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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